The US Food and Drug Administration has accepted a new filing seeking the green light for the oncology agent, Tarceva (erlotinib), in the treatment of pancreatic cancer, OSI Pharmaceuticals revealed yesterday. The news provides an added bonus for OSI, as it triggers a $7 million dollar milestone payment from partner Genentech.
Tarceva was filed with the FDA in this new indication back in May [[03/05/05e]]. The companies are specifically seeking the green light for use together with Eli Lilly’s Gemzar (gemcitabine) in the treatment of advanced pancreatic cancer patients who have not previously been treated.
Tarceva, which is currently approved in the US to treat non-small cell lung cancer [[22/11/04d]], has been granted priority review classification by the FDA, meaning that the agency has six months from receipt of the filing, or until November 2, 2005, to take action.
The American Cancer Society predicts that in 2005 about 32,180 people in the United States will be diagnosed with pancreatic cancer and about 31,800 will die of the disease. Although pancreatic cancer accounts for 2 percent of new cancer cases in the United States, it is the fourth leading cause of all cancer deaths.